This invention relates generally as indicated to a low profile gastrostomy device which is especially designed to be inserted through an opening in the wall of the abdomen and stomach of a patient for use in supply nutrients and other fluids including medication into the stomach. Also, such a device can be used for decompression, and provides access for examination endoscopically, for example, using fiber optics. Other uses requiring insertion of a tube into other viscera of the body may be made of the device, such as urinary bladder drainage, ileostomy, jejunostomy, and cystostomy.
Certain medical conditions require the long term access for such purposes as internal feedings and/or medication to a person's stomach or other viscera of the body. This may be accomplished by inseting a tube through a surgical opening into the stomach or other viscera.
Problems with conventional gastrostomy tubes are common in both adults and children. These range from stomal irritation to more serious mishaps. Accidental removal and internal migration are also oftentimes encountered with conventional gastrostomy tubes.
To eliminate these problems, the low profile gastrostomy device of the present invention was developed which is simple in design and use, is substantially flush with the skin, and is self-retaining and non-refluxing. Such device is also biocompatible, long lasting, and can be used in an established gastrostomy.
One type of skin level feeding gastrostomy tube is disclosed in U.S. Pat. No. 4,315,513. The device shown in such patent includes a malecot tip on the inner end of the tube for retaining the tube in the stomach and an exterior assembly which rests substantially flush against the outside abdominal wall. A skin protector disk is disposed between an outer flange on the external assembly and the exterior of the abdominal wall to space the external assembly a slight distance from the abdominal wall so as to allow air to reach the underlying skin. Also, a one-way valve is mounted within the exterior assembly to prevent the back flow of fluids or gas from the stomach without having to clamp a tube extension. A cap may be used to close off the outer end of the tube when not in use.
Also, U.S. Pat. No. 3,915,171 shows another gastrostomy tube including a first retention bulb at the inner end of the tube which is disposed in bearing engagement against the inside stomach wall and a second inflatable retention bulb spaced from the first retention bulb to engage the outer abdominal wall when inflated. A plug is removable from the outer end of the tube to open the tube as desired. The plug is connected to the tube by a flexible strap to prevent the plug from being separated from the tube.
These devices have the drawback that they are relatively large and rigid, may be made of natural rubber, and are complicated and expensive to make. Also, the exterior retention devices are potentially irritating to the skin, and are not as flush with the skin as one would like. Some devices also require the use of a retention balloon and an access port for inflation and deflation.